Continuous glucose monitoring systems generally include a sensor such as a subcutaneous analyte sensor, at least a portion of which is configured for fluid contact with biological fluid, for detecting analyte levels such as for example glucose or lactate levels, a transmitter (such as for example an RF transmitter) in communication with the sensor and configured to receive the sensor signals and to transmit them to a corresponding receiver unit by for example, using RF data transmission protocol. The receiver may be operatively coupled to a glucose monitor that performs glucose related calculations and data analysis.
The transmitter may be mounted or adhered to the skin of a patient and also in signal communication with the sensor. Generally, the sensor is configured to detect the analyte of the patient over a predetermined period of time, and the transmitter is configured to transmit the detected analyte information over the predetermined period of time for further analysis. To initially deploy the sensor so that the sensor contacts and electrodes are in fluid contact with the patient's analyte fluids, a separate deployment mechanism such as a sensor inserter or introducer is used. Moreover, a separate base component or mounting unit is provided on the skin of the patient so that the transmitter unit may be mounted thereon, and also, to establish signal communication between the transmitter unit and the analyte sensor.
As discussed above, the base component or mounting unit is generally adhered to the skin of the patient using an adhesive layer that is fixedly provided on the bottom surface of the base component or the mounting unit for the transmitter.
To minimize data errors in the continuous or semi-continuous monitoring system, it is important to properly insert the sensor through the patient's skin and securely retain the sensor during the time that the sensor is configured to detect analyte levels. In addition to accurate positioning of the sensor through the skin of the patient, it is important to minimize the level of pain associated with the insertion of the sensor through the patient's skin.
Additionally, for the period of continuous or semi-continuous monitoring which can include, for example, 3 days, 5 days or 7 days, it is important to have the transmitter unit securely mounted to the patient, and more importantly, in proper contact with the analyte sensor so as to minimize the potential errors in the monitored data. Indeed, when mounted onto the skin using adhesives, bodily fluid such as sweat and muscle flexure may weaken the adhesive securing the transmitter unit onto the skin surface, and which may potentially cause the transmitter unit to detach from the skin prematurely.
In view of the foregoing, it would be desirable to have methods and apparatuses which would minimize the number of components that are needed for the patient to manipulate in order to deploy the sensor and the transmitter unit to properly be initialized and set-up so that the sensor may be configured to monitor a biological fluid to detect, for example, analyte levels of the patient and the transmitter unit may be configured to transmit data associated with the detected analyte levels of the patient. Further, it would be desirable to have methods and apparatuses that include an integrated sensor insertion mechanism and transmitter mount or housing portion which may be mounted on the patient's skin securely, with ease and relatively little pain to the patient.